A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus

Study title: 
A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus
Long title: 
A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in subjects with clinical recent-onset Type 1 Diabetes Mellitus (T1D).
Date receipt dossier: 
20 Jun 2018
EU record number: 
B/BE/18/BVW5
EudraCT number: 
2016-004161-68
Company / Sponsor: 
Intrexon T1D Partners, LLC
Phase: 
Ib/II
Treated organism: 
Humans
Indication category: 
Metabolic disorders
Disease: 
Type 1 Diabetes Mellitus (T1D)
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin
Administered biological material: 
GM Lactococcus lactis
Route of administration: 
Oral
Locations in Belgium: 
UZ Gasthuisberg, Leuven; UZ Brussel; UZ Antwerpen, Edegem
Nr of subjects: 
The clinical trial will enroll a total of 48 participants. Among these 48 patients, only 10 will be enrolled in Belgium.
Foreseen duration: 
From 01/08/2018 until 31/08/2019
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

Information for the public

Information related to the decision procedure